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Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors
Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedDecember 17, 2020
December 1, 2020
5 months
April 13, 2017
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in MetD
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.
From week 25 to week 49
Secondary Outcomes (3)
Change in cardiorespiratory fitness
Baseline to week 49
Change in functional capacity
Baseline to week 49
Change in muscle strength
Baseline to week 49
Study Arms (3)
Group I (PCT)
EXPERIMENTALPatients undergo supervised exercise sessions comprising of AE over 30 minutes and RE over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
Group II (PAT)
EXPERIMENTALPatients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
Group III (usual care)
ACTIVE COMPARATORPatients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I.
Interventions
Undergo usual care
Correlative studies
Receive Polar heart rate monitor
Ancillary studies
Eligibility Criteria
You may qualify if:
- Newly diagnosed (stage I-III) breast cancer
- Self-identify as Latina
- Have undergone a lumpectomy or mastectomy
- Have received and completed neoadjuvant or adjuvant cytotoxic chemotherapy and/or radiation therapy within the past 12 months
- Have no evidence of cancer disease after treatment (confirmed by their treating physician)
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; obtains clearance from physician to confirm status)
- Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) \> 30 kg/m\^2 (calculated using height and weight) or body fat \> 30% (estimated by bioelectrical impedance), and waist circumference \> 35 inches (in)
- Free from history of chronic disease including severe diabetes (glycosylated hemoglobin \[HgA1c\] \> 7% requiring a pharmacologic intervention), uncontrolled hypertension or thyroid disease (obtains clearance from physician to confirm status)
- Have not experienced a weight reduction \>= 10% within past 6 months; and body weight has remained stable for the past 4 weeks
- Currently participate in less than 60 minutes of physical activity/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy if use will be continued for duration of study period
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided)
You may not qualify if:
- Currently pregnant
- History of chronic disease including uncontrolled diabetes, uncontrolled hypertension or uncontrolled thyroid disease; women using metformin to manage diabetes will be excluded from the trial
- Weight reduction \>= 10% within past 6 months
- Metastatic disease
- Planned reconstructive surgery with flap repair during trial and follow-up period
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, Ph.D.
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 19, 2017
Study Start
March 8, 2019
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
December 17, 2020
Record last verified: 2020-12